We are currently recruiting subjects aged 18 to 65 years old with moderate-to-severe alopecia areata for a study that evaluates the safety, effectiveness, and tolerability of an investigational treatment called daxdilimab. Alopecia areata is an autoimmune disease resulting in hair loss that is usually in one or more coin-shaped patches on the face, scalp or other areas of the body that grows hair. It should be noted that subjects with the presence of traction alopecia would not be eligible for this study.
The study consists of an investigational treatment that will be administered subcutaneously (by injection under the skin) every 4 weeks, for 32 weeks. There is no placebo for this study and all participants will be receiving the treatment.
During the study visits, several assessments and procedures will be conducted to assess your eligibility for the study.
This study will last 1 year and will include up to 14 visits. There is a 12-week post-treatment follow-up period lasting from Week 32 to Week 48 as the final planned clinic visit. Visit duration are between 1-3.5 hours, except for your screening visit that may take up to 4 hours, your Day 1 visit that may take up to 5.5 hours and your week 4 visit that may take up to 4.5 hours.
Blood samples will be taken throughout the course of the study. Photographs of the full scalp, as well as eyebrows and eyelashes, for patients who have hair loss in these areas, will also be taken during the study.
Your participation in this study is at no cost to you.
Compensation for travel and expenses may be provided if deemed eligible.
